Cleared Traditional

DualCap

K142806 · Catheter Connections, Inc. · General Hospital
May 2015
Decision
235d
Days
Class 2
Risk

About This 510(k) Submission

K142806 is an FDA 510(k) clearance for the DualCap, a Cap, Device Disinfectant (Class II — Special Controls, product code QBP), submitted by Catheter Connections, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 22, 2015, 235 days after receiving the submission on September 29, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K142806 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2014
Decision Date May 22, 2015
Days to Decision 235 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code QBP — Cap, Device Disinfectant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440
Definition Disinfect Needleless Access Valves And May Act As A Physical Barrier To Contamination If Not Removed For A Set Period Of Time